NCT01202292

Brief Summary

The overall goal of IMOAP study is to assess whether the efficacy of the healthcare professionals' usual practices, together with a motivational group intervention (delivered by a nurse trained by an expert psychologist), is more effective than an isolated traditional intervention on weight loss and its maintenance in overweight and obese patients. Furthermore, the study will evaluate whether this result has a positive impact on quality of life, changes in eating habits, and a reduction in the associated cardiovascular risk factors and overall cardiovascular risk.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

October 1, 2010

Status Verified

September 1, 2010

Enrollment Period

1.8 years

First QC Date

May 31, 2010

Last Update Submit

September 30, 2010

Conditions

OverweightObesity

Keywords

overweightobesitymotivational intervention

Outcome Measures

Primary Outcomes (1)

  • Determine whether a group motivational intervention, is more efficient than the latter in the treatment of overweight and obesity, for initial weight loss and essentially to achieve sustained normalisation of the weight achieved.

    26 months

Secondary Outcomes (1)

  • Observe whether this intervention is more effective for reducing cardiovascular risk factors associated to overweight and obesity, and in the overall cardiovascular risk in these patients.

    26 months

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL
Behavioral: Behavioral (e.g., Psychotherapy, Lifestyle Counseling)

Interventions

Behavioral (e.g., Psychotherapy, Lifestyle Counseling)BEHAVIORAL

Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise

Also known as: Control group receives the usual follow up: diet, exercise
Lifestyle counseling

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Overweight (BMI\>25) and obese (BMI\>30) patients of both sexes, registered in the medical history (MH) or newly diagnosed.
  • Aged between 30 and 70 years
  • Agreement to participate in the study

You may not qualify if:

  • Patients with severe clinical pathology (bedridden, dementia, advanced neoplasia, etc.)
  • Patients with secondary obesity (hypothyroidism, Cushing's disease, etc)
  • Patients with severe sensorial disorders capable of interfering with the motivational intervention (severe, uncorrected deafness, severe visual deficit, etc).
  • Patients with serious psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ABS Florida Sud

L'Hospitalet Del Llobregat, Barcelona, 08095, Spain

RECRUITING

Related Publications (1)

  • Rodriguez Cristobal JJ, Panisello Royo JM, Alonso-Villaverde Grote C, Perez Santos JM, Munoz Lloret A, Rodriguez Cortes F, Trave Mercade P, Benavides Marquez F, Marti de la Morena P, Gonzalez Burgillos MJ, Delclos Baulies M, Bleda Fernandez D, Quillama Torres E; IMOAP Group. Group motivational intervention in overweight/obese patients in primary prevention of cardiovascular disease in the primary healthcare area. BMC Fam Pract. 2010 Mar 18;11:23. doi: 10.1186/1471-2296-11-23.

    PMID: 20298557BACKGROUND

MeSH Terms

Conditions

OverweightObesity

Interventions

PsychotherapyExercise

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Juan José Roodriguez-Cristóbal, Dr

    Catalan Institute of Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Jose Rodriguez-Cristóbal, Dr

CONTACT

003493447108021002jrc@comb.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2010

First Posted

September 15, 2010

Study Start

January 1, 2008

Primary Completion

October 1, 2009

Study Completion

December 1, 2010

Last Updated

October 1, 2010

Record last verified: 2010-09

Locations

ES(1)